Interventional surgical procedures in the urinary tract system such as prostate surgery or trans-urethral resection typically require the insertion of an indwelling urological catheter for bladder drainage and to permit irrigation of the bladder. Urological catheters can be either 3-way and 2-way foley catheters or suprapubic catheters that are inserted through the abdomen into the bladder. Foley catheters used in these surgical procedures are called 3-way catheters in that they have three ports having a center port for drainage, a first side port for inflating the internal retention balloon, and a second side port for infusion of irrigation fluid and for aspiration of blood clots. The center port is usually attached to a drainage bag for collection of drainage. The second side port is called the irrigation access port, which is sealed closed with the insertion of a simple plastic catheter plug. Blood clots and accumulated body tissue within the bladder need to be flushed out through the irrigation port using continuous irrigation or catheter tip irrigation syringe of 60 cc capacity. Irrigation syringes are either the squeeze bulb type or the piston type, but all irrigation syringes have a large bore tapered catheter tip. These irrigation syringes with catheter tips have no standard dimensions and vary as to length and degree of taper. Post-operative recovery of the urological surgical patient can take up to several weeks and requires repeated catheter irrigations as often as once every hour. This means that the catheter plug must be removed to insert the irrigation syringe that causes the clinician to come in contact with potentially infectious urinary drainage fluid opening the urinary drainage system is often the cause of introducing outside contamination in the body that can cause urinary tract infections. As such, the current catheter plug device is messy and presents difficulties for both the patient and clinician.
The usual practice is to use a continuous irrigation set attached directly into the side irrigation port of a 3-way foley catheter to deliver a continuous stream of irrigation fluid through the catheter into the bladder. After about 24-48 hours continuous irrigation is discontinued and catheter tip intermittent irrigation is substituted.
Two-way foley catheters are more prevalent since they are more compact and clinicians believe that opening and closing the irrigation port on a 3-way catheter can promote more urinary tract infections. The one major advantage of a 3-way foley catheter, however, is that the clinician does not have to disconnect the catheter from the urinary drainage connector and bag in order to irrigate the catheter and bladder. As such, the 2-way catheter must be disconnected from the drainage bag if irrigation of the catheter or bladder is necessary to flush out blockages of the catheter or debris in the bladder. This disconnection of the catheter from the drainage bag is a well-documented cause of urinary tract infections as well as a messy procedure that exposes the clinician to potentially infectious urine. Also, disconnection and intermittent syringe irrigation of a 2-way foley catheter requires considerable nursing skill, expense, and expertise to accomplish.
To date, the inventor is not aware of any prior art inventions specifically designed to provide a closed system irrigation connector for urinary catheters. The prior art, however, is filled with inventions for intravenous syringe ports, needle-less I.V. access ports for small bore luer tip or luer lock syringes, or closed adapters for delivery of enteral formula.
Reference should be made to recently issued U.S. Pat. No. 6,344,033 to Jepson et al tided “Needleless Connector” which describes in detail valves and connectors used in IV. Therapy and is very comprehensive in listing all the prior art patents and inventions.
Also, U.S. Pat. No. 6,165,168 to Russo issued Dec. 26, 2000 and its referenced patents should also be considered. With all of this it is important to note that no commercial product has been invented or is commercially available which specifically addresses or solves the prevalent occurrence of urinary tract infections caused by the open type irrigation procedures presently used.